ES2589181T3 - Pet food compositions and methods to treat arthritis and arthritis-associated inflammation - Google Patents

Abstract

Pet food composition comprising a source of myristic acid and a source of beta carotene, in amounts effective to treat arthritis or arthritis-associated inflammation, in which myristic acid is present in an amount of at least 0, 3%, and in which beta-carotene is present in an amount of at least 2 ppm.

Description

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DESCRIPTION

Pet food compositions and methods for treating arthritis and arthritis-associated inflammation Field of the invention

The present invention relates to pet food compositions and methods for treating arthritis and arthritis-associated inflammation in a companion animal, particularly canids and felines.

Background of the invention

Rheuma and arthritis are general terms for acute and chronic conditions characterized by inflammation and pain. Rheuma is a general category of conditions characterized by inflammation and pain in the muscles and joints, including arthritis. Arthritis is characterized by inflammation of the joints that causes swelling and pain. Types of arthritis include osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (AD) and systemic lupus erythematosus. The reason for such diseases is not always fully understood but may be the result of other degenerative diseases, trauma or autoimmune diseases.

Inflammation refers to an attempt of protection by an organism to eliminate a harmful stimulus and initiate the healing processes of the tissue affected by the harmful stimulus. The inflammation takes place as a defense response to the invasion of the host by foreign agents and mechanical trauma that result in an immune response, for example, microbial agents such as bacteria and viruses, toxins and neoplasia. The inflammation can be classified as either acute or chronic. Acute inflammation is an initial response to harmful stimuli and is achieved by increasing the movement of plasma and leukocytes from the blood to the damaged tissues. A cascade of biochemical reactions propagates and develops the inflammatory response, which involves the local vascular system, the immune system and various cells within the damaged tissue. Chronic inflammation or prolonged inflammation leads to a progressive change in the type of cells, which are present at the site of inflammation, and is characterized by the simultaneous destruction and healing of tissue from the inflammatory process.

The above methods for preventing and treating inflammatory diseases have generally focused on oral medications such as steroid cortisone derivatives and numerous non-steroidal anti-inflammatory drugs (NSAIDs). Unfortunately, these drugs have undesirable side effects. Other efforts have focused on joint implants such as knee or hip implants. These methods involve prolonged and expensive surgical procedures that force the patient to undergo invasive surgery with a significant recovery period.

In the face of problems with current methods for the treatment of arthritis and inflammation associated with arthritis, there is a continuing need for new methods and compositions useful for the treatment of arthritis and inflammation associated with arthritis and, in particular, Food compositions effective in treating these conditions.

EP1602284 discloses a method for producing fractions containing a high concentration of basic milk cystatin and breakdown products thereof.

US2006 / 0228448 discloses pet food compositions comprising a first component comprising a source of protein, a source of fat and a source of carbohydrate, and a second composition comprising a biological product selected from a component probiotic; yeast; enzymes; antibodies; immunoglobulins; cytokines; and combinations thereof.

Document US6,669,975 discloses a personalized dietary health management system for pets. Brief summary of the invention

The present disclosure provides an effective functional food-based approach to treat arthritis and arthritis-associated inflammation. The use of a combination of mirlastic acid and beta-carotene in nutritionally complete pet food composition, such as a nutritionally complete food for dogs or felines composition, is described. A food composition of the invention may, for example, include a combination of tomato pulp, coconut oil and carrot powder.

In one aspect, the present invention provides a composition according to claim 1. In another aspect, the present invention provides a use according to claim 13.

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A pet food composition is provided that includes a source of mirlstic acid and a source of beta-carotene, in amounts effective to treat arthritis and inflammation associated with arthritis. The source of mirlstic acid can, for example, include or consist of coconut oil, and the source of beta-carotene can include or consist of at least one of tomato pulp and carrot powder.

A method is also provided for treating arthritis and arthritis-associated inflammation in a companion animal such as a canine or a feline, which includes feeding a companion animal in need of such treatment with a composition of the invention. The composition can, for example, feed the animal as its main nutritionally complete or unique food on a daily basis.

It also provides the use of a source of mirlstic acid and a source of beta-carotene for the manufacture of a pet food composition, such as a nutritionally complete food, for the treatment of arthritis and inflammation associated with arthritis in a companion animal, such as a canido or a feline.

The use of a source of mirlstic acid and a source of beta-carotene is also provided for the manufacture of a pet food composition, such as a nutritionally complete food, for the treatment of arthritis and arthritis-associated inflammation. in a companion animal, such as a canido or a feline.

Additional areas of applicability of the present invention will be apparent from the detailed description provided below in this document. It should be understood that the detailed description and specific examples, although indicating the preferred embodiment of the invention, are only intended to illustrate and are not intended to limit the scope of the invention.

Detailed description

The following description of the preferred embodiments is simply by way of example and is not intended to limit the invention, its application or uses in any way.

As used throughout the document, intervals are used to briefly describe each of all the values that are within the range. Any value within the interval can be selected as the end of the interval.

In case of conflict between a definition in the present disclosure and that of a cited reference, the present disclosure prevails.

Unless otherwise specified, all percentages and quantities expressed herein and anywhere in the specification should be understood as referring to percentages by weight.

As used herein, "an effective amount" and similar terms refer to the amount of a compound, a material or a composition as described herein that may be effective in achieving a particular biological result. Such results may include, but are not limited to, treatment of arthritis or inflammation associated with arthritis. Such effective activity can be achieved, for example, by administering compositions of the present invention to an animal. An effective amount may be based on several factors, including an ideal weight of the animal and the frequency of feeding the animal with compositions of the present invention, for example, once, twice or three times a day, and feeding the animal with other compositions.

As used herein, the term "main food composition" means the food for nutritionally complete main food with which the canine or feline is fed from day to day.

As contemplated herein, the compositions of the present invention are intended to encompass balanced and nutritionally complete animal feed compositions. A "nutritionally complete diet" is a diet that includes enough nutritional substances in the diet to maintain normal health of a healthy animal. Balanced and nutritionally complete pet food compositions are familiar to a person skilled in the art. For example, substances such as nutritional substances and ingredients suitable for balanced and nutritionally complete animal feed compositions and recommended amounts thereof, can be found, for example, in the official publication of The Association of American Feed Control Officials, Inc. ( AAFCO), Atlanta, GA, 2005.

For example, a balanced and nutritionally complete dog food composition of the present invention may include: from about 0 to about 90%, preferably from about 5% to 60%, by weight of carbohydrates; from about 5% to about 70%, preferably from about 10% to about 60%, more preferably from about 20% to about 50%, by weight of protein; from about 1% to about 50%, preferably from about 2% to about 40%, more preferably from about

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3% to about 15%, by weight of fat; from about 0.1% to about 40%, preferably from about 1% to about 30%, more preferably from about 15% to about 50%, by weight of total dietary fiber; from about 0 to about 15%, preferably from about 2% to about 8%, by weight of vitamins and minerals, antioxidants and other nutrients that support the animal's nutritional needs.

The protein can be supplied by any of a variety of sources known to those skilled in the art, including plant sources, animal sources or both. Animal sources include, for example, meat, meat by-products, seafood, dairy products, eggs, etc. Meats include, for example, chicken meat, fish and mammals (for example, cattle, pigs, sheep, goats and the like). Meat by-products include, for example, lungs, kidneys, brain, liver, and stomachs and intestines (free of all or essentially all of their contents). The protein may be intact, almost completely hydrolyzed or partially hydrolyzed. The amount of "crude protein" in a composition disclosed herein can be determined based on the amount of nitrogen in the composition according to methods familiar to a person skilled in the art. As contemplated herein, the compositions of the present invention may include from about 5% to about 70% of protein, from about 10% to about 60% of protein, from about 20% to about 50% of protelna, from about 25% to about 40% of protelna, and from about 29% to about 38% of protelna.

In certain embodiments, nutritionally complete pet food compositions disclosed herein may include fat. Sources of fat for the compositions of the present invention can be supplied by any of a variety of sources known to those skilled in the art, including meat, meat by-products, fish oil and plants. Vegetable fat sources include wheat, flax seeds, rye, barley, rice, sorghum, maize, oats, millet, wheat germ, maize germ, soybeans, peanuts and cottonseeds, as! as oils derived from them and other sources of vegetable fat. As contemplated herein, the compositions of the present invention may include from about 1% to about 20% fat, from about 2% to about 18% fat, from about 3% to about 15% fat, from about 7% to about 14% fat, and from about 9% to about 12% fat.

Carbohydrate can be supplied by any of a variety of sources known to those skilled in the art, including oat fiber, cellulose, peanut husks, beet pulp, steamed rice, malted starch, maize gluten meal and any combination of these sources. Cereals that supply carbohydrates include, but are not limited to, wheat, maize, barley and rice. The carbohydrate content of foods can be determined by any of the various methods known to those skilled in the art. Generally, the percentage of carbohydrates can be calculated as a nitrogen-free extract ("NFE") that can be calculated as follows:

NFE = 100% -% humidity -% protein -% ash -% crude fiber

Total dietary fiber refers to components of a plant that are resistant to digestion by the digestive enzymes of an animal. Total dietary fiber includes soluble and insoluble fibers. As contemplated herein, the compositions of the present invention may include from about 15% to about 50% of total dietary fiber, from about 16% to about 45% of total dietary fiber, from about 17% to about 40% of total dietary fiber, from about 18% to about 35% of total dietary fiber, from about 19% to about 30% of total dietary fiber, and from about 20% to about 29% of total dietary fiber.

Soluble fiber is resistant to digestion and absorption in the small intestine and undergoes complete or partial fermentation in the large intestine. Sources of soluble fiber may include beet pulp, guar gum, chicory root, psyllium, pectin, blue cranberries, red cranberries, squash, apples, oats, beans, citrus, barley or peas. Insoluble fiber can be supplied through any of a variety of sources, including cellulose, whole wheat products, oatmeal, maize bran, flax seeds, grapes, celery, green beans, cauliflower, potato skins, fruit skins, Vegetable skins, peanut peels and soy fiber.

The crude fiber includes indigestible components contained in the cell walls and the cellular content of plants such as cereals, for example, cereal husks such as rice, maize and beans.

The invention is also described in the following examples. The examples are simply illustrative and do not limit the scope of the invention in any way as described and claimed.

Examples Example 1

General methods and materials

Compositions for animals were prepared as follows: each feed was crushed and formulated according to the 5-nutrient substance for cats and dogs of the Association of American Feed Control Officials and balanced to meet adult maintenance requirements. Animals were cared for according to the protocols of the Institutional Animal Care and Use Committee.

Blood or serum samples were stored at -80 ° C until analysis. Samples were extracted and prepared for analysis using conventional solvent extraction methods. The extracted samples 10 were divided equally for analysis on the GC / MS and LC / MS / MS platforms in a random series order. The data for each compound was normalized by calculating the mean values for each serial day ("block normalization").

Data were analyzed using either SAS version 9.0 or a t-test to determine treatment differences. T tests were used for paired data to determine if there were significant changes with respect to the reference (month 0). The unit of experimentation was a canid (dog) or feline (cat) and the differences were considered significant when P <0.05.

Reference Example 2

Study of arthritis in canidos (dogs)

A feeding study was carried out for canines with arthritis to evaluate the efficacy of a test formula, formula CA, in arthritic markers and activity in 36 arthritic and 21 normal elderly dogs. The effect of the test formula was evaluated using an Actiwatch system (activity), chemical tests, CBC, biological markers of blood and urine cartilage, metabolomics, proteomics and genomics. In the study, the dogs were fed with control food for 28 days and then fed with control food (formula CC) or the test formula, formula CA, for 28 more days to assess changes in arthritic parameters in dogs 25 arthritic and normal elders.

The study used 36 dogs with arthritis with radiographic evidence of arthritis and a history of lameness that occurs naturally and 21 healthy normal elderly dogs without radiographic evidence of arthritis or lameness history.

The medication was removed from the dogs with any medication during the wash period at least 7 days before day 0 of the treatment period to ensure that the collected reference samples were indicative of the true status of the dogs.

During the 28-day test period, blood samples were collected at days 0 and 28 for analysis of serum chemistry, CBC, biological markers in blood and urine, genomics, proteomics and metabolomics. The arthritic dogs carried the Actiwatch system during the study to collect information on changes in their activities.

35 During the entire duration of the study, body weights were recorded weekly and food intake daily.

If dogs were diagnosed with diseases such as kidney disease, cancer, hypothyroidism, Cushing's disease or another disease, they withdrew from the study and received the appropriate treatment for their pathological conditions. In addition, dogs that refused to eat at least 25% of their assigned food for 40 more than four days or had weight losses exceeding 2.0% weekly, withdrew from the study. If any treatment was necessary to treat any other medical condition that involved changing the dog to another food for more than four days, the dog was withdrawn from the study.

The compositions used in the study are described in the table below.

Table 1. Composition of nutritional substances of the food used in the study

 Nutritive substance, 100% dry matter basis

 Canido control formula, CC formula Canido test formula, CA formula

 Gross protein,%

 18.51 29.6

 Nutritive substance, 100% dry matter basis

 Canido control formula, CC formula Canido test formula, CA formula

 Grease, %

 17.19 11.67

 Crude fiber, %

 1.29 15.0

 Total dietary fiber,%

 7.86 * 29.4

 Soluble fiber, %

 0.57 * 3.0

 Insoluble fiber,%

 7.28 * 26.4

 Ca,%

 0.69 0.88

 P,%

 0.58 0.69

 Potassium,%

 0.55 0.78

 Magnesium,%

 0.09 0.17

 Sodium,%

 0.30 0.36

 Chloride,%

 0.66 0.88

 Lysine,%

 0.89 * 1.59

 Methionine,%

 0.36 * 1.29

 Arachidonic acid,%

 0.07 * 0.05

 Mirlstic acid,%

 0.12 * 0.49

 Laurato,%

 0.01 * 1.17

 Alpha-linolenic acid,%

 0.11 * 0.76

 L-carnitine, ppm

 12 * 268

 Lipoic acid, ppm

 - 105.43

 * Values formulated

In the reference, arthritic dogs had significantly higher serum alkaline phosphatase levels compared to normal elderly dogs, indicating a higher systemic inflammation.

Table 2. Seric chemical levels in the reference

 Seric Chemistry Exam

 Arthritic dogs Normal dogs Probability of arthritis *

 Seric alkaline phosphatase

 220.56 123.14 0.05

 * Mixed ANOVA procedure

Dogs (arthritic and normal) fed the test formula had a significant reduction in the 5 serum levels of alkaline phosphatase, cholesterol and triglycerides compared to those that were fed the control formula.

Table 3. Seric chemical levels of arthritic dogs after feeding.

 Seric Chemistry Test

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 Day 28 Day 0 Day 28

 Seric alkaline phosphatase

 216.28 118.89 <0.01 224.83 272.78 0.08 <0.01

 Seric cholesterol

 212.5 167.39 <0.01 198.28 211.83 0.04 <0.01

 Serum Triglycerides

 171.89 46.83 <0.01 144.17 129.11 NS <0.01

 * ANOVA, t test

Table 4. Seric chemical levels of normal dogs after feeding.

 Seric Chemistry Test

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 Day 28 Day 0 Day 28

 Seric alkaline phosphatase

 118.3 82.2 0.03 127.55 133.55 NS 0.02

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Seric cholesterol

 218.7 179 <0.01 202.36 203 NS <0.01

 Serum Triglycerides

 156 62.9 0.01 130.82 94.73 0.09 <0.01

 * ANOVA, t test

Arthritis dogs fed the test formula had significantly reduced levels of BAP (alkaline bone phosphatase) and ghrelin compared to dogs fed the control formula. BAP is a marker of bone formation and directly reflects osteoblastic activity.

Table 5. Biological markers in serum and urine of arthritis dogs after feeding

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 Day 28 Day 0 Day 28

 BAP, U / l

 16.4 12.54 <0.01 20.58 25.22 0.08 <0.01

 Ghrelin, ng / ml

 4.57 4.78 NS 5.29 5.03 0.08 0.05

 * ANOVA, t test

5 Additional changes were observed in arthritic dogs in response to the test formula, including a reduction in the BAP ratio: NTx (bone-specific alkaline phosphatase: N-terminal cross-linked type I collagen telopeptide) and a change in nocturnal activity in response to the test formula compared to the control formula. NTx measures a type I collagen cleavage product and reflects bone degradation or renewal.

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Table 6. Biological markers in serum and urine of arthritis dogs after feeding

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 Day 28 Day 0 Day 28

 BAP Reason: NTx

 1.38 1.04 <0.01 1.61 1.93 0.08 <0.01

 * ANOVA, t test

Table 7. Night activity levels of arthritic dogs

 Formula CC Formula CA Formula CC vs. CA formula *

 Activity

 Mean day ± SD Average ± SD

 Night

 0 43.04 ± 4.38 45.68 ± 4.61 NS

 28 48.12 ± 5.59 41.43 ± 5.26 NS

 Day 28 - Day 0 5.09 ± 2.48 -4.25 ± 4.11 0.06

 * ANOVA, t test

Normal dogs fed the test formula had a significant reduction in BAP levels and the BAP: NTx ratio and a significant increase in NTx levels compared to dogs fed the control formula.

15 Table 8. Biomarkers in serum and urine of normal dogs after feeding

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 | Day 28 Day 0 | Day 28

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 BAP, U / l

 13.34 11.06 <0.01 15.79 15.37 NS <0.01

 BAP Reason: NTx

 1.08 0.69 0.02 1.47 1.39 NS <0.01

 NTx, nM ECB

 15.1 17.09 NS 11.41 12.14 NS 0.03

 * ANOVA, t test

In general, dogs (arthritic and normal) fed the test formula had a decrease in BAP the reason BAP: NTx compared to dogs fed the control formula. Arthritic dogs fed the test formula had a decrease in ghrelin levels compared to dogs fed the control formula.

5 Table 9. Biological markers in serum and urine of arthritic and normal dogs after feeding

 Seric Chemistry Exam

 Formula CA Day 0 against day 28 * Formula CC Day 0 against day 28 * Formula CC against formula CA *

 Day 0 Day 28 Day 0 Day 28

 BAP, U / l

 16.31 12.01 <0.01 18.76 21.48 NS <0.01

 BAP Reason: NTx

 1.27 0.91 <0.01 1.56 1.72 NS <0.01

 Ghrelin, ng / ml

 4.43 4.70 NS 5.14 4.89 0.09 0.01

 * ANOVA, t test

The results indicate that the test formula was effective in reducing bone and inflammatory conditions and therefore may be useful for the treatment of arthritis and inflammation associated with arthritis.

Example 3

Study of arthritis in felines (cats)

10 A feeding study was carried out for felines with arthritis with 26 arthritic and 27 normal elderly cats using conditions similar to those described in example 2.

If cats were diagnosed with diseases such as kidney disease, cancer, hypothyroidism or another disease, they withdrew from the study and received the appropriate treatment for their pathological conditions. In addition, cats that refused to eat at least 25% of their assigned food for more than four days or had 15 weight losses exceeding 2.0% weekly, withdrew from the study. If any treatment was necessary to treat any other medical condition that involved changing the cat to another food for more than four days, the cat was removed from the study. The test formula for felines was the FA formula and the control formula for felines was the FC formula.

The composition of the food used for the study is provided below:

20 Table 10. Profiles of nutritional substances formulated from the two foods used in the study

 Nutritive substances, 100% dry matter basis

 Feline control formula, FC formula Feline test formula, FA formula

 Gross protein,%

 34.25 37.95

 Grease, %

 20.18 11.39

 Crude fiber, %

 2.56 10.46

 Total dietary fiber

 4.76 * 20.05

 Soluble fiber, %

 0.45 * 2.62

 Insoluble fiber,%

 4.31 * 17.43

 Ca,%

 0.92 0.96

 P,%

 0.84 0.81

 Potassium,%

 0.60 0.80

 Nutritive substances, 100% dry matter basis

 Feline control formula, FC formula Feline test formula, FA formula

 Sodium,%

 0.45 0.27

 Magnesium,%

 0.08 0.11

 Chloride,%

 0.77 0.73

 Mirlstic acid,%

 0.17 * 0.36

 Lauric acid,%

 0.01 * 0.86

 Alpha-linoleic acid,%

 0.14 * 1.16

 L-carnitine, ppm

 21 * 639

 Beta-carotene, ppm

 - 3.56

 Methionine,%

 0.93 * 1.39

 Lysine,%

 1.59 * 2.12

 * Values formulated

In the reference, arthritic cats had higher levels of alkaline phosphatase and higher phosphorus levels, but lower cholesterol levels compared to normal elderly cats and had higher levels of CTXII (C-terminal cross-linked type II collagen fragment) in urine, of IL-1 beta (interleukin-1 beta) in serum and BAP in serum and a lower ratio of CPII: CTXII (C-terminal collagen propeptide type II: C-5 cross-linked fragment of type II collagen ) compared to normal elderly cats. CTXII measures the cross-linked C-terminal fragment of type II collagen after being cleaned by MMP (matrix metalloproteinases). CPII is a product of excision of the mature molecule of type II collagen that almost exclusively forms the articular cartilage. IL-1 beta is a cytokine produced by macrophages activated as proprotelna and is an important mediator of the inflammatory response.

10 Table 11. Seric chemical levels in the reference

 Seric Chemistry Test

 Arthritis cats Normal cats Probability of arthritis *

 Seric alkaline phosphatase

 47.5 38.52 0.03

 Match

 4.44 4 <0.01

 Cholesterol

 140.38 157.2 0.04

 * Mixed ANOVA procedure

Table 12. Biological markers in serum and urine in the reference

 Seric Chemistry Test

 Arthritis cats Normal cats Probability of arthritis *

 CTXII urine, ug / l

 7.83 6.18 0.05

 IL-1 beta, pg / ml

 884.94 351.53 0.03

 BAP, U / l

 7.83 6.18 0.05

 Reason CPII-CTXII in urine

 53.45 82.51 <0.01

 * Mixed ANOVA procedure

Arthritic cats fed the test formula had significantly reduced levels of CTXII, CPII in urine and had reduced levels of HMGB1 compared to those of cats fed the control formula.

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Table 13. Biological markers in serum and urine of arthritic cats after feeding

 Seric Chemistry Test

 Formula FA Day 0 vs. Day 28 * Formula FC Day 0 vs. Day 28 * Formula FC vs. Formula FA *

 Day 0 Day 28 Day 0 Day 28

 CTXII in urine, ug / l

 59.25 57.95 NS 48.54 32.23 0.01 0.02

 CPII, ng / ml

 1355.2 1486.9 NS 1274.9 1178.6 NS 0.02

 HMGBI, ng / ml

 0.4 0.34 NS 0.72 0.26 NS 0.07

 * ANOVA, t test

In general, cats (arthritic and normal) fed the test formula had a decrease in the levels of CTXII and IGF-1 (insulin growth factor) and the PIIANP: C2C ratio (N-terminal propeptide procollagen type IIA: fragment of length 3/4 C-terminal of type II collagen) in urine compared to cats fed the control formula. In addition, cats fed the test formula had a reason

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CPII: CTXII increased compared to that of cats fed the control formula. The C2C molecule is cleaved at various positions by MMP (matrix metalloproteinases) during the cartilage degradation process. PHANP is also a product released during the synthesis of the type II collagen molecule but reflects a different cleavage point during processing.

Table 14. Biological markers in serum and urine of arthritic and normal cats after feeding

 Seric Chemistry Exam

 Formula FA Day 0 against day 28 * Formula FC Day 0 against day 28 * Formula FC against formula FA *

 Day 0 Day 28 Day 0 Day 28

 CTXII in urine, ug / l

 43.8 40.41 NS 35.15 24.62 <0.01 0.01

 PIIANP Reason: C2C

 5.46 4.52 NS 5.6 4.38 <0.01 0.03

 IGF-1, ng / ml

 273.76 268.9 NS 268.89 225.92 0.01 0.02

 Reason CPII: CTXII in urine

 64.31 57.18 NS 63.08 92.12 <0.01 0.01

The results indicate that the test formula was effective in reducing bone and inflammatory conditions and therefore may be useful for the treatment of arthritis and inflammation associated with arthritis.

In view of the above, the following is provided without limitation:

A pet food composition is provided that includes mirlstic acid, such as mirlstic acid from a plant source, and beta-carotene, such as beta-carotene from a plant source, in amounts effective to treat arthritis or inflammation associated with arthritis in a companion animal such as a canine or feline. The source of mirlstic acid may, for example, include or consist of coconut oil, palm oil, palm kernel oil, crystalline myristate or mixtures thereof. The source of beta-carotene may, for example, include or consist of at least one of tomato pulp and carrot powder or it may include or consist of kale, common squash, roman mint, spinach, squash and sweet potato. The amount of beta-carotene in the compositions of the invention is at least 2 parts per million (ppm), such as in the range of 2-4 ppm. Pet food compositions may optionally include lipoic acid.

Compositions that include mirlstic acid in an amount of at least about 0.1% and at least about 0.2% are described. The compositions of the invention include mirlstic acid in an amount of at least about 0.3%.

In one embodiment, mirlstic acid is provided at least predominantly by coconut oil in the composition and beta-carotene is provided at least substantially by tomato pulp, carrot powder or mixtures thereof in the composition. In another embodiment of the invention, the amount of tomato pulp is from about 2% by weight to about 8% by weight, the amount of coconut oil is from

about 0.5% by weight to about 6.0% and the amounts of carrot powder are about

about 0.1% by weight to about 2.0% by weight.

In a further embodiment, the composition includes from about 20% by weight to

approximately 50% by weight of total protein, from approximately 15% by weight to

about 50% by weight of total dietary fiber and from about 3% by weight to about 15% by weight of fat.

A method is also provided for treating arthritis or arthritis-associated inflammation in a companion animal, such as a canine or feline, which includes feeding a companion animal in need of such treatment with a composition of the invention. The composition can, for example, be fed to the animal as a main nutritionally complete or unique food on a daily basis.

The composition can be fed to the animal at least once a day. The feeding of the animal with the composition can be continued at least once a day after the animal shows improvement. The composition may, for example, be fed to the animal at least once a day for at least one week, for at least one month, for at least 2 months or for at least 3 months. As demonstrated herein, such feeding positively affects the biological markers of inflammation and health of bones and cartilage. By

For example, such feeding reduces the serum level of the animal's alkaline phosphatase.

The use of mirlstic acid, such as a vegetable source of mirlstic acid, for example, coconut oil, and a source of beta-carotene, such as a vegetable source of beta-carotene, for example at least one of pulp is also provided. of tomato and carrot powder, for the manufacture of a pet food composition, such as a nutritionally complete food, for the treatment of arthritis or inflammation associated with arthritis in a companion animal, such as a canido or a feline

Natural plant sources of mirlstic acid and beta-carotene are preferred but the invention is not limited to such sources. Embodiments corresponding to those described, but using beta-carotene and / or synthetic or purified mirlstic acid are also within the scope of the invention.

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Claims (13)

5 10 fifteen twenty 25 30 1. Pet food composition comprising a source of mirlstic acid and a source of beta-carotene, in amounts effective to treat arthritis or inflammation associated with arthritis, in which mirlstic acid is present in an amount of at minus 0.3%, and in which beta-carotene is present in an amount of at least 2 ppm. 2. Composition according to claim 1, wherein said source of mirlstic acid comprises coconut oil and said source of beta-carotene comprises at least one of tomato pulp and carrot powder. 3. Composition according to claim 2, wherein the amount of tomato pulp is from 2% by weight to 8% by weight; the amount of coconut oil is 0.5% by weight to 6.0%; and the amount of carrot powder is 0.1% by weight to 2.0% by weight. 4. Composition according to any previous claim comprising: from 20% by weight to 50% by weight of total protein; from 15% by weight to 50% by weight of total dietary fiber; and from 3% by weight to 15% by weight fat. 5. Composition according to any previous claim, which also includes lipoic acid. 6. Composition according to any previous claim, in which the companion animal is a canine or a feline. 7. Composition according to any preceding claim, for use in the treatment of arthritis or inflammation associated with arthritis in a companion animal, treatment comprising feeding a companion animal that needs such treatment with the composition. 8. Composition for use according to claim 7, wherein the animal is fed with the composition at least once a day. 9. Composition for use according to claim 8, wherein the animal is fed with the composition at least once a day for at least one week. 10. Composition for use according to claim 9, wherein the animal is fed with the composition at least once a day for at least one month. 11. Composition for use according to claim 10, wherein the animal is fed with the composition at least once a day for at least two months. 12. Composition for use according to any one of claims 7-11, wherein the companion animal is a canine or a feline. 13. Use of a source of mirlstic acid and a source of beta-carotene for the manufacture of a pet food composition for the treatment of arthritis or inflammation associated with arthritis in a companion animal, in which the acid mirlstico is present in an amount of at least 0.3% and in which beta-carotene is present in an amount of at least 2 ppm.